Early Clinical and Radiographic Outcomes of Robot‐Assisted Versus Conventional Manual Total Knee Arthroplasty: A Randomized Controlled Study

OBJECTIVE: Robot‐assisted surgery has been promoted worldwide in recent years. The development of a domestic orthopaedic robot and its clinical application are therefore of great significance. This study aimed to compare the early clinical and radiographic outcomes of domestic robot‐assisted total knee arthroplasty (RA‐TKA) with conventional manual total knee arthroplasty (CM‐TKA). METHODS: A total of 77 patients who underwent primary single‐sided TKA from June to December 2020 were prospectively enrolled; resulting in the inclusion of 72 patients. The patients were randomly divided into the RA‐TKA group (37 cases, with TKA being assisted by the Yuanhua Orthopaedic Robotic System) and the CM‐TKA group (35 cases, with TKA being performed using conventional tools). Knee function was evaluated by the knee range of motion (ROM), the American Knee Society Score (KSS), and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Postoperative radiographic results were evaluated by full‐length weight‐bearing X‐rays of the lower limb and anteroposterior and lateral X‐rays of the knee were obtained preoperatively and at 90 days postoperative. The operative duration, blood loss, postoperative knee function, radiographic outcomes, and incidence of complications were compared by Student's t‐test, Mann–Whitney U test, or chi‐square test. Serum levels of inflammatory markers before the operation and 1, 3, and 30 days after the operation were recorded and compared between the two groups. RESULTS: The operation was significantly longer in the RA‐TKA group than in the CM‐TKA group (154.3 vs 115.2 min, p < 0.001). There was no significant difference in blood loss (933 vs 863 ml, p = 0.519) between the two groups. The knee ROM, KSS, and WOMAC were significantly improved in both groups 90 days after the operation compared with before the operation (p < 0.05), but there were no significant differences between the two groups (p > 0.05). The incidence of postoperative deep vein thrombosis was not statistically different between the two groups. In the radiographic findings at 90 days postoperatively we found the frequency of lateral tibial component (LTC) angle outliers was significantly lower in the RA‐TKA group (3.0% vs 29.4%, p = 0.003). The neutrophil‐to‐lymphocyte ratio (NLR) was significantly lower in the RA‐TKA group than in the CM‐TKA group on day 1 after surgery (9.9 vs 12.7, p = 0.024). CONCLUSIONS: RA‐TKA requires more time than CM‐TKA, which may be related to the learning curve and intraoperative registration. The short‐term postoperative knee functional outcomes had no differences between the two groups, and RA‐TKA improved the accuracy of tibial component alignment. Further follow‐up studies are required to investigate the long‐term outcomes.